Inside the Pill Bottle: A Comprehensive Guide to the Pharmaceutical Industry
By Dr Raafet
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About this ebook
"Inside the Pill Bottle: A Comprehensive Guide to the Pharmaceutical Industry" is a definitive resource that delves deep into the world of pharmaceuticals. This comprehensive book provides a thorough exploration of the pharmaceutical industry, offering invaluable insights and in-depth analysis. Whether you are a student, researcher, or simply curious about the inner workings of this vital sector, this guide is your key companion.
Dr Raafet
"My name is Dr. Raafet. 'Dr.' refers to my last name, Dhkar, as well as my professional title as a doctor. I hold a PhD in Pharmacy and I am passionate about sharing knowledge with others. In order to provide easy access to knowledge, I publish my work on open platforms at an affordable price. This allows students, researchers, and anyone interested to obtain valuable information without financial barriers. I believe in the importance of granting individuals the opportunity to expand their understanding and contribute to the field of pharmacy."
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Book preview
Inside the Pill Bottle - Dr Raafet
Summary
Chapter 1:
Contact with the pharmaceutical industry
II. Personnel
1. Company organization chart
Chapter 2:
The quality assurance system
II. The audit
III. Marketing authorisation dossier (MA)
Drug circuit: Study of a Specialty X ®
I. Medicinal product circuit
II. Follow-up of the manufacturing steps of a specialty X®
III. Deposits/Operating Conditions
Chapter 4: Familiarization with physicochemical, pharmaco-technical and microbiological control equipment
Chapter 1:
Contact with the pharmaceutical industry
I. Premises and environment:
❖ Galenic forms: examples of specialties
❖ Different statuses of medicinal products
Generic drugs: This is the production and marketing of generic drugs under the brand name of the laboratory.
Drugs manufactured under license from major international pharmaceutical groups such as: GlaxoSmithkline, Sanofi, Bouchara-Recordati, MerckLipha, Astra Zeneca, Pierre Fabre Pharmaceutical, Abbott and Solvay
Manufactured medicines: manufactured on behalf of third-party laboratories, contractors.
1. Premises:
There are usually three manufacturing sites at the industry site
This provision complies with the rules of good manufacturing practice
According to GMP 2014
In order to reduce the risk of serious accidents attributable to cross-contamination, such as certain sensitizing agents (such as penicillin) or biological preparations (from living micro-organisms). the production of other drugs (certain hormones or cytotoxics and other highly active or non-drug products should not be carried out in the same premises"
The manufacturing sites are composed of:
Stores (MP/AC AND PF)
The weighing unit
Dry form manufacturing workshops:
- 3 wet granulation centers
- 3 drying centers
- 3 mixing centers
- 3 compression centers
- 1 capsule placement center
Workshops for the manufacture of liquid forms:
- Syrups
- Suspensions
- Antiseptic solutions
Packaging workshops
The control laboratory
A storage area for rejected products
A flammable storage area
Technical rooms comprising:
- A water and steam boiler room
- A local air compressor
- A local electrical transformer station
- Emergency generators
- A wastewater treatment plant from the plant
- The purified water treatment plant.
- The air handling unit
› MP/AC storage area
The MP/AC storage warehouse at the alpha plant is designed and arranged to ensure the safety of stored products that guarantee their good preservation.
The MP/AC storage organization allows rotation based on the first in first out
(FIFO) principle taking into account the expiry date.
PM and CAs not yet released are kept in physical and computer